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Drug Test
February 28, 2025
FDA issues class-wide labeling changes for testosterone products
FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,
Drug Test
February 28, 2025
Generic Drugs Program Activities Report – FY 2024 Monthly Performance
This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications.…
Drug Test
February 28, 2025
Generic Drugs Program Monthly and Quarterly Activities Report
Monthly and quarterly metrics of the FDA Generic Drugs Program.
Drug Test
February 28, 2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions – 03/13/2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Drug Test
February 28, 2025
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from…
Drug Test
February 28, 2025
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 12/04/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…
Drug Test
February 28, 2025
Global Trends and Methodological Challenges in Hair Toxicology: A Survey‐Based Analysis
Drug Testing and Analysis, EarlyView.
Drug Test
February 28, 2025
Biology and Management of Male‐Bodied Athletes in Elite Female Sports
Graphical representation of the relationships of transgender and XY DSDF as male-bodied athletes along the binary dimensions of biological sex.…
Drug Test
February 27, 2025
Jobs at CDER Frequently Asked Questions
Frequently Asked Questions about GDUFA Hiring Initiative
Drug Test
February 27, 2025
POSTPONED – Optimizing Pregnancy Registries – 03/27/2025
Public workshop is part of FDA’s commitment to advance optimal approaches to efficient generation of high-quality human safety data for…
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